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The effect of local ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in adult: Randomized clinical trial with concurrent control group

The effect of local ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in adult: Randomized clinical trial with concurrent control group

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231216060427N2
Enrollment
42
Registered
2024-07-01
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillitis. Chronic diseases of tonsils and adenoids

Interventions

Intervention 1: Intervention group: This study will be conducted on people over 18 years of age who undergo tonsil

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age over 18 years recurrent or chronic tonsillitis (7 or more episodes of sore throat per year for two consecutive years or 3 or more episodes of sore throat per year for three years) suspicion of tonsil malignancy upper airway obstruction secondary to tonsillar hypertrophy (obstructive sleep apnea) recurring abscesses around the tonsils the ability to communicate verbally provide written consent

Exclusion criteria

Exclusion criteria: A history of drug addiction taking painkillers more than 4 times a week peripheral neuropathy antipsychotic drugs history of cardiovascular diseases history of arrhythmia

Design outcomes

Primary

MeasureTime frame
Primary outcome: pain The patient's pain in recovery, 6 hours after the operation and 24 hours after the operation will be measured with the VAS scale and by the technician or nurse present in the recovery and ward in a blind manner and without the knowledge and knowledge of the local injection of ketamine. VAS (visual analog scale) Visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement tool for mental characteristics or attitudes that cannot be measured directly. When answering a VAS item, respondents indicate their level of agreement with a statement by indicating a position along a continuous line between the two endpoints. It is common to use this scale to measure pain. In the numerical part, the person rates their pain using a scale of 0 to 10. 0 means no pain, 1-2 mild pain, 3-4 moderate pain that interferes with activity, 5-6 moderate pain that interferes with concentration, 7-8 severe pain that interferes with meeting basic needs and -10 9. The pain is very intense and unbearable. Timepoint: In recovery, 6 hours after surgery and 24 hours after surgery. Method of measurement: It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

Secondary

MeasureTime frame
3- Dysrhythmia The occurrence of dysrhythmias in the patient will be investigated during recovery under cardiac monitoring blindly and without knowledge of local injection of ketamine. Timepoint: In recovery. Method of measurement: It will be measured blindly by the technician or nurse present in the recovery without the knowledge of the local injection of ketamine.;4- Hemodynamics The patient's hemodynamics, including heart rate, saturation, blood pressure, and respiratory rate during recovery, 6 hours after surgery, and 24 hours after surgery will be measured blindly by a technician or nurse present in the recovery room and department without the knowledge of local injection of ketamine. . Timepoint: In recovery, 6 hours after surgery and 24 hours after surgery. Method of measurement: It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.;5- Bleeding The occurrence of bleeding after surgery in the recovery, 6 hours after the operation and 24 hours after the operation will be checked by the technician or the nurse present in the recovery and the department blindly and without the knowledge and knowledge of the local injection of ketamine. Timepoint: In recovery, 6 hours after surgery and 24 hours after surgery. Method of measurement: It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.;1-Nausea and vomiting: The patient's nausea in the recovery, 6 hours after the operation and 24 hours after the operation will be evaluated verball

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Heidari

Mazandaran University of Medical Sciences

drMahsaheidari@gmail.com+98 11 3304 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026